MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. CT MIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	MLCT4S20FN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rn placed a midline following standard procedure.Attempted to flush and removed wire and cut catheter.Proceeded as usual, when catheter was in place, user noted that it would not flush.Attempted to trouble shoot several times but ended up removing.After device was removed it was noted that the catheter end had sealed together leaving only a pin hole resulting in being unable to pass fluid for a flush.Device was pulled, and a new line was placed in the other arm.

• Brand Name: CT MIDLINE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8443210
• Report Number: 8443210
• Device Sequence Number: 19564630
• Product Code: LJS
• UDI-Device Identifier: 00884908113631
• UDI-Public: 00884908113631
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/07/2019
• Report Date (Section F): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MLCT4S20FN
• Device Catalogue Number: MLCT4S20FN
• Device Lot Number: MMAN080
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/07/2019